CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Policy governs medical-benefit coverage and prior authorization for Fensolvi (leuprolide acetate subcutaneous extended-release), Lupron Depot-Ped (leuprolide acetate depot IM), and Triptodur (triptorelin IM extended-release) for central precocious puberty and for pubertal suppression in gender-dysphoric/gender-incongruent persons. It defines approved dosing regimens, prescribing specialist requirement, durations of approval, and exclusions.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision (dosage update + administrative)

Effective DateOct 23, 2024

Next Review Date

Key ActionObtain prior authorization for Fensolvi, Lupron Depot-Ped, and Triptodur per the policy; ensure specialist prescribing/consultation for gender‑dysphoric indications and request extensions if patient continues to meet criteria.

SourceLink

POLICY UPDATE CHANGES

Lupron Depot-Ped dosage: frequency updated to include 12 weeks on the 3-month depot and added 6-month depot (45 mg) given IM once every 6 months (24 weeks).

Annual Revision on 10/23/2024: No criteria changes noted in latest annual revision summary (administrative).

2Covered Indications (listed)

1Excluded Indication

3Products covered

Coverage Summary

Scope: Policy governs medical-benefit coverage and prior authorization for Fensolvi (leuprolide acetate subcutaneous extended-release), Lupron Depot-Ped (leuprolide acetate depot IM), and Triptodur (triptorelin IM extended-release) for central precocious puberty and for pubertal suppression in gender-dysphoric/gender-incongruent persons. The policy defines approved dosing regimens, a specialist prescribing/consultation requirement for gender-dysphoric indications, durations of approval, and exclusions.

Coverage stance: Covered with criteria. Approvals are typically provided for 1 year (with extended approvals allowed if criteria continue to be met). Effective/last review date: 2024-10-23. Approved indications at a high level: central precocious puberty (FDA-approved) and pubertal suppression for gender-dysphoric/gender-incongruent persons (off-label). Products covered: Fensolvi, Lupron Depot-Ped, Triptodur. Typical approval duration is 1 year (with dosing/authorization described per product).

Key Policy Facts

Policy subjectGonadotropin-Releasing Hormone (GnRH) Agonists for Precocious Puberty and Gender Dysphoria

PayerCareSource

Policy typeUTILIZATION MANAGEMENT MEDICAL POLICY

Effective date2024-10-23

Last review2024-10-23

StatusCURRENT

Number

Products coveredFensolvi, Lupron Depot-Ped, Triptodur

Covered IndicationsCentral precocious puberty; Gender-dysphoric/gender-incongruent pubertal suppression

Excluded IndicationPeripheral (GnRH-independent) precocious puberty

Conditions Not Recommended for Approval

Peripheral precocious puberty (also termed GnRH-independent precocious puberty) is defined as a form of precocious puberty that does not respond to GnRH agonist therapy; children with this condition require alternative treatment directed at removing or blocking excess sex steroids or using glucocorticoids for defects in adrenal steroidogenesis.

Referenced Products / Codes

Drugs referenced (medical benefit)mixedCovered

Fensolvi (leuprolide acetate subcutaneous extended-release)	45 mg injection every 6 months (documented dosing option)
Lupron Depot-Ped (leuprolide acetate depot IM)	1-month depot: 7.5 mg, 11.25 mg, or 15 mg once monthly; 3-month depot: 11.25 mg or 30 mg every 12 weeks; 6-month depot: 45 mg every 24 weeks
Triptodur (triptorelin IM extended-release)	22.5 mg injection every 24 weeks

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Fensolvi, Lupron Depot-Ped, and Triptodur. Approvals are typically provided for one year, with extended approvals allowed if the patient continues to meet the policy criteria and documented dosing.

Documentation Required

Specialist prescribing / consultation requirement for gender-dysphoric indications

For gender-dysphoric/gender-incongruent indications, the product must be prescribed by or in consultation with an endocrinologist or a physician who specializes in the treatment of transgender patients.

Billing Rule

Dose requests outside established dosing

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis and reviewed by a clinician (Medical Director or Pharmacist).

Denial Risk

Not recommended: Peripheral precocious puberty

Claims for GnRH agonists for peripheral (GnRH-independent) precocious puberty are not recommended for approval and may be denied, because children with peripheral precocious puberty do not respond to GnRH agonist therapy.

Background & Evidence

Background: GnRH agonists (including leuprolide and triptorelin) are the standard of care for central precocious puberty and are effective across formulations and routes of administration. These agents are also used off-label for pubertal suppression in gender-dysphoric/gender-incongruent patients. Long-acting GnRH analogs are preferred for pubertal suppression; treatment is generally reversible (pubertal development resumes on discontinuation) and decisions on duration and regimen are individualized.

Evidence summary: Guideline support includes a 2009 consensus statement and an international consortium update (2019) endorsing GnRH agonist use in central precocious puberty and noting effectiveness across agents. The 2019 update highlights the lack of prospective comparative studies to establish superiority of one agent over another, and therefore does not prefer one GnRH agonist over another.

Term	Definition
Peripheral precocious puberty	GnRH-independent precocious puberty which does not respond to GnRH agonist therapy; requires alternative treatment directed at excess sex steroids or adrenal steroidogenesis defects.

Revision History

10/23/2024administrative_review

Annual Revision on 10/23/2024: No criteria changes noted in latest annual revision summary (administrative).

11/08/2023material_revisionLatest

Lupron Depot-Ped dosing updated: 3-month depot frequency specified as every 12 weeks and a 6-month depot (45 mg) added given intramuscularly once every 6 months (24 weeks).

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual Revision (dosage update + administrative)

Effective DateOct 23, 2024

Next Review Date

SourceLink

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UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Recommended Authorization Criteria

Conditions Not Recommended for Approval

Referenced Products / Codes

Provider Actions & Authorization Requirements

Background & Evidence

Revision History